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FDA regulatory speed-up for early drug development
The FDA is proposing an “optional, risk-based” expedited Investigational New Drug pathway designed to move certain experimental drugs into human testing faster, aligning with a framework the...
M&A: Neurocrine moves to buy Soleno for PWS therapy
Neurocrine Biosciences announced a $2.9 billion acquisition of Soleno Therapeutics, valuing the deal at $53 per share in cash. The purchase adds Soleno’s Vykat XR (diazoxide choline), the only...
Biotech funding: Stipple Bio emerges with $100M for novel oncology targets
Stipple Bio launched with a $100 million Series A financing to advance STP-100, an antibody-drug conjugate (ADC) aimed at an undisclosed target, while also building its Pointillist discovery...
Neural diagnostics: Multimodal MRI plus machine learning targets earlier Parkinson’s detection
New research highlights a multimodal machine-learning strategy for earlier Parkinson’s disease detection by combining quantitative susceptibility mapping (QSM) with magnetic resonance spectroscopy...
Oncology immunotherapy mechanism: restoring dendritic-cell mitochondrial function boosts checkpoint responses
A St. Jude Children’s Research Hospital team reported in Science that tumors can disable dendritic cells by reprogramming mitochondrial metabolism, weakening the cells’ ability to initiate...
Precision oncology testing: Netherlands data supports routine whole-genome sequencing in cancer care
Researchers in the Netherlands argued in Nature Medicine that whole-genome sequencing (WGS) should be incorporated into routine cancer care, proposing it can identify clinically actionable...
Regenerative/biomarker tech: MethylScan low-cost cfDNA methylome test for multi-disease screening
UCLA scientists disclosed an affordable blood test, MethylScan, designed to detect multiple cancers and liver disorders simultaneously by analyzing cell-free DNA methylation patterns. The approach...
Regenerative engineering: Mayo Clinic nanotherapy crosses the blood–brain barrier in glioblastoma models
Mayo Clinic researchers developed an experimental dual-drug nanotherapy intended to penetrate the blood–brain barrier and deliver treatment directly to glioblastoma tumors. The preclinical...
Neurodegeneration deal fallout: Takeda terminates Denali partnership over restructuring
Takeda ended its long-running co-development partnership with Denali Therapeutics, returning full rights to DNL593 ahead of the asset’s next clinical steps amid Takeda restructuring. The...
Regulatory designation: FDA grants Fast Track to TRI-611 in ALK-positive NSCLC
The FDA granted Fast Track designation to TRI-611 for ALK-positive non-small cell lung cancer, positioning the program for potential expedited interaction with the agency during development....
Neurocrine’s $2.9B move into Prader-Willi hyperphagia therapy
Neurocrine Biosciences agreed to buy Soleno Therapeutics in a $2.9 billion cash deal, paying $53 per share—a 34% premium to Soleno’s prior close. The acquisition adds Soleno’s Prader-Willi...
FDA proposes accelerated early-phase path; Takeda exits Denali dementia program
The FDA’s 2027 budget proposal outlined a potential new “optional, risk-based” expedited Investigational New Drug pathway that would allow some experimental drugs to enter U.S. Phase 1 testing...
Regulatory turbulence and outcomes for small biotechs and telehealth
A STAT+ report described how Kezar Life Sciences closed its doors after an FDA meeting on trial design was canceled months after the company had reached an agreement—leaving no clear path forward....
Amgen pushes Tepezza competitive defenses with injectable Phase 3 data
Amgen reported that an injectable version of Tepezza (teprotumumab-trbw) succeeded in a Phase 3 study for thyroid eye disease, setting up direct competition with Viridian Therapeutics’ recently...
Oncology genomics debate heats up: push for routine whole-genome sequencing
Dutch researchers argued in Nature Medicine that whole-genome sequencing (WGS) should be incorporated into routine cancer care, using real-world data from 888 patients treated at the Netherlands...
Multi-disease liquid biopsy: UCLA’s cfDNA methylation MethylScan
UCLA scientists unveiled MethylScan, a low-cost blood test aimed at simultaneously detecting multiple cancers and non-malignant conditions using cfDNA methylome profiling. Early studies in more...
Genomics and immunology infrastructure: ASHOP integrates hematologic ‘omics’
St. Jude Children’s Research Hospital, the American Society of Hematology (ASH), and Munich Leukemia Laboratory launched the ASH HematOmics Program (ASHOP), described as an integrative data...
Trial design and digital compliance: BMS adopts Faro AI for protocols
Bristol Myers Squibb will use artificial intelligence to develop clinical trial protocols in partnership with Faro Health, marking the drugmaker’s second AI-focused deal in as many months. The...
Biotech funding momentum: Syneron peptides funding and Stipple launches
Syneron Bio raised $150 million in a Series B to develop a peptide drug class, extending investment momentum from its prior $100 million round. The new capital supports program development and...
Drug development strategy shift: charged molecular glue discovery via targeted degron display
A Nature Chemical Biology study reported a discovery strategy for charged molecular glues enabled by targeted degron display. The work describes a method to identify small molecules that promote...